Can Nebulised HepArin Reduce acuTE lung injury in Patients with SARS-CoV-2 Requiring Advanced Respiratory support in Ireland - Charter Trial

IG0 个研究点目标入组 40 人开始时间: 2020年8月14日最近更新: 2022年5月16日

试验速览

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•To be eligible, a patient must satisfy all these inclusion criteria:
•1. Confirmed or suspected COVID-19. Note, if ‘suspected’, results must be pending or testing intended
•2. Ability to obtain informed consent/assent to participate in study
•3. Age 18 years or older
•4. Requiring high flow nasal oxygen or positive pressure ventilator support or invasive mechanical ventilation in the ICU / HDU for a time period of no greater than 48 hours
•5. D-dimers > 200 ng/ml
•6. PaO2 to FIO2 ratio less than or equal to 300
•7. Acute opacities on chest imaging affecting at least one lung quadrant. Note ‘Acute opacities’ do not include effusions, lobar/lung collapse or nodules
•8. Currently in a higher level of care area designated for inpatient care of patients where therapies including non-positive pressure ventilatory support can be provided.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•To be eligible, a patient must have none of these exclusion criteria:
•1. Enrolled in another clinical trial that is unapproved for co-enrolment
•2. Heparin allergy or heparin-induced thrombocytopaenia
•3. APTT > 100 seconds
•4. Platelet count < 50 x 109 per L
•5. Pulmonary bleeding, which is frank bleeding in the trachea, bronchi or lungs with repeated haemoptysis or requiring repeated suctioning
•6. Uncontrolled bleeding
•7. Pregnant or suspected pregnancy (Urine or serum HCG will be recorded)
•8. Receiving or about to commence ECMO or HFOV
•9. Myopathy, spinal cord injury, or nerve injury or disease with a likely prolonged incapacity to breathe independently e.g. Guillain-Barre syndrome
•10. Usually receives home oxygen
•11. Dependent on others for personal care due to physical or cognitive decline (pre-morbid status)
•12. Death is imminent or inevitable within 24 hours
•13. The clinical team would not be able to set up the study nebuliser and ventilator circuit as required including with active humidification
•14. Clinician objection.
•15. The use or anticipated use of nebulised tobramycin during this clinical episode
•16. Any other specific contraindication to anticoagulation including prophylactic anticoagulation not otherwise listed here
•17. Relapse in clinical condition in patient that had weaned from advanced respiratory support
•18. Receiving any direct / novel oral anticoagulant

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